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FDA Again Stalls on Over-the-Counter Status for Emergency Contraception

August 29, 2005

More than a year and a half after two of its expert advisory committees voted 23 to 4 to recommend approval for unrestricted access, the U.S. Food and Drug Administration (FDA) has indefinitely postponed any decision to allow nonprescription status for Plan B emergency contraception (EC)—popularly known as the “morning-after pill.”

The FDA is delaying any action to make the method available while they gather public comments. At the December 16, 2003, advisory committee hearing, medical and health organizations provided expert testimony in favor of the switch to over-the-counter status. In addition to the FDA’s advisory committees and staff scientists, major medical groups including the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the American Public Health Association have endorsed over-the-counter status. Women in Western Europe and Canada can already buy similar products without a prescription.

The FDA is holding up timely access to EC while they debate the legality and feasibility of making the method available to adult women over-the-counter and to women aged 16 and younger as a prescription-only drug. The FDA actually recommended that Plan B’s manufacturers request this dual status as a way to address FDA concerns that young women will misuse or abuse the pills. Studies included in the original April, 2003, application indicate the drug is safe for young teens and show that easier access does not lead to greater risk-taking by teens. Medical experts argue that teens are the very people who may need emergency contraception most, because they are more likely than adults to have unprotected sex and have less experience with regular contraception.

Emergency contraception consists of the same hormone (a progestin) found in ordinary birth control pills. It is not the same as the abortion pill, mifepristone (an anti-progestin). Timely access to emergency contraception is critical, because the pills are more effective the sooner they are taken. Delays caused by the need to obtain and fill prescriptions (particularly over weekends and holidays) can reduce the product’s effectiveness and may prevent many women from starting treatment in time to avoid a pregnancy. Research from the Guttmacher Institute suggests that in 2000, use of emergency contraceptives averted more than 100,000 unintended pregnancies, helping women to avoid an estimated 51,000 abortions.

Legislatures in a number of states have already taken steps to improve access to emergency contraceptives. Seven states allow pharmacists in collaborative practice agreements with physicians to dispense the pills, and six states require hospital emergency rooms to provide treatment to women who have been sexually assaulted. Major medical groups are also recommending that doctors dispense the drug in advance for women to keep in their medicine cabinet.